Clear21

Bracket, Ceramic, Orthodontic

World Class Technology Corporation

The following data is part of a premarket notification filed by World Class Technology Corporation with the FDA for Clear21.

Pre-market Notification Details

Device IDK192202
501k NumberK192202
Device Name:Clear21
ClassificationBracket, Ceramic, Orthodontic
Applicant World Class Technology Corporation 1300 NE Alpha Dr. Mcminnville,  OR  97128
ContactAlan Kozlowski
CorrespondentAlyssa Thomas
Allegiance Regulatory Consulting LLC 16642 SW Lansford Ct. Beaverton,  OR  97007
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-14
Decision Date2019-11-12

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